Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 5, 2012
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the desig…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Steris Corporation recalled QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization t… - a moderate-severity action.
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization t… was recalled by Steris Corporation in September 5, 2012. Reason: STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtai…. Check the official notice for the remedy. Verify recall #Z-2284-2012 with the FDA Devices before acting.
The recall
Steris Corporation issued this moderate-severity FDA Devices recall-STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtai….
- Moderate
- severity level
- 64 units
- affected scope
- Class II
- classification
- September 5, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2284-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2284-2012) was formally reported on September 5, 2012, with the manufacturer initiating the action on August 10, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Steris Corporation is listed as the recalling firm, operating out of Mentor, OH. Federal records list the affected scope as 64 units.
The documented reason for this recall is: STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick conne… Distribution data in the federal record shows the product reached: Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
64 units
Related Recalls
6
3 from same agency
Product description
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
Reason for recall
STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2284-2012 |
| Date reported | September 5, 2012 |
| Date initiated | August 10, 2012 |
| Recalling firm | Steris Corporation |
| Firm location | Mentor, OH |
| Affected scope | 64 units |
| Distribution | Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2284-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.. Recalled by Steris Corporation. Units affected: 64 units.
Why was this product recalled? ▼
STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2284-2012.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2284-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 5, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.